The purpose of this study is to investigate if 14 weeks of pazopanib therapy prior to surgery (nephrectomy) is of benefit to patients with metastatic renal cancer. Ninety-five patients will be recruited into his study.
This is a Phase II, open label study evaluating pre-operative pazopanib treatment in previously untreated patients with metastatic clear cell renal cancer. This study follows a Simon 2 stage design Patients will take pazopanib for 14 weeks followed by a nephrectomy. The drug will continue after nephrectomy until disease progression is documented. Patients will come off study once disease progression occurs, where they will then be followed for survival. Subsequent treatment at the discretion of the treating physician will be documented. After surgery, all patients will be radiologically evaluated 8 weekly until progression. Standard radical nephrectomy with lymph node dissection will be performed on those patients who are deemed operable. The surgery can be laparoscopic or open. Those not deemed suitable for nephrectomy after 14 weeks of treatment will be offered a repeat biopsy.
Study Type
OBSERVATIONAL
Enrollment
95
Basildon and Thurrock University Hospitals NHS Foundation Trust
Basildon, United Kingdom
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Clinical benefit of 14 weeks of pre-operative pazopanib therapy, prior to nephrectomy using RECIST 1.1 criteria
12 week CT scan will be compared to the baseline CT scan using RESIST criteria 1.1 to assess whether the patients have benefited from the upfront pazopanib treatment.
Time frame: Interim analysis after 34 patients have 12 weeks of treatment
Surgical complications (blood loss, post operative complications, hospital stay)
Following surgery information regarding the quantity of blood loss, time the surgery took, length of hospital stay and whether there were any surgical complications will be recorded.
Time frame: After the first 20 patients have had a nephrectomy
Overall Survival
Overall survival will be measured from start of treatment to time of death.
Time frame: After three years of study
Progression free survival
Progression free survival will be measured from start of study treatment to time of disease progression.
Time frame: After all patients have progresssed
Local response of primary tumour to pazopanib
Time frame: After 12 weeks of study drug
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Barts and London Hospital NHS Trust
London, United Kingdom
Oncology & Clinical Haematology Trials Unit, Royal Free Hospital
London, United Kingdom
Oncology & Haematology Clinical Trials Unit, Guy's Hospital
London, United Kingdom
Department of Oncology Oxford Cancer Centre
Oxford, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
Southend University Hospital Trust
Southend, United Kingdom